Abstract：
:The global biopharmaceutical market is worth over $100 billion USD. Nearly 90% of these products will lose their patent in the next ten years, leading to the commercialization of their subsequent versions, known as 'biosimilars'. Biosimilars are much more complex molecules than chemically synthesized generics in terms of size, structure, stability, microheterogeneity, manufacture, etc. Therefore, a specific regulatory framework is needed in order to demonstrate their comparability with innovative products, as well as their quality, safety and efficacy. The EU published the first regulatory pathway in 2005 and has approved 14 biosimilars. Mexico has recently developed a clear regulatory pathway for these products. Their legal basis was established in Article 222 Bis of General Law of Health in 2009, clear specifications in the Regulation for Health Goods in 2011, and further requirements in the Mexican Official Norm NOM-EM-001-SSA1-2012. The aim of this review is to summarize the regulatory pathways for biosimilars in the world with a special focus on Mexican experience, so as contribute to the development of regulations in other countries.
journal_name
Biotechnol Advjournal_title
Biotechnology advancesauthors
Ibarra-Cabrera R,Mena-Pérez SC,Bondani-Guasti A,García-Arrazola Rdoi
10.1016/j.biotechadv.2013.05.005subject
Has Abstractpub_date
2013-12-01 00:00:00pages
1333-43issue
8eissn
0734-9750issn
1873-1899pii
S0734-9750(13)00086-4journal_volume
31pub_type
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